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Medical device leaders will gather in Toronto this week for Advamed’s MedTech conference, one of the medical technology industry’s largest gatherings. The summit will bring together more than 3,900 people from 48 countries to discuss medtech trends and global regulatory developments.
The event comes at a critical moment in the medical device industry. The Food and Drug Administration is looking for a new director for its Center for Devices and Radiological Health as the former head faces questions about conflicts of interest. New rules governing lab-developed tests are also being challenged in court ahead of the US presidential election.
MedTech Davey will be in Toronto covering the conference this week. Here are four trends we’re seeing:
1. New Chief of CDRH
FDA Tool Center leaders will share the agency’s top priorities and field questions during the session Mayor on Thursday. Michel Turor, who was Named as guardian CDRH is scheduled to speak at this meeting in July. Former CDRH Director Jeff Shurin is also listed as a speaker on the agenda. Shurin stepped ahead of the U this summer New York Times report That raised concerns about potential conflicts of interest during his 15 years leading the department. Two House Democrats The Office of the Inspector General requested an investigation Following the report, which focused on how Shurin led CDRH while his wife worked as a legal consultant for medtech companies.
CDRH is looking for a permanent successor.
Other CDRH leaders who spoke at the event included Owen Farris, principal deputy director of the Office of Product Evaluation and Quality; Troy Tazbaz, director of the FDA’s Digital Health Center; and Daniel Canvas, director of CDRH’s Office of Clinical Evidence and Analysis.
2. Focus on AI
as a The rise of medical devices Use artificial intelligence, regulators are intensifying their focus on the technology. Several sessions at the conference address how AI is being used in the hospital setting, how to address concerns about bias and accuracy, and how to navigate new regulations.
On Tuesday, Tazbaz and Marc Lamoureux, director of the Digital Health Division for the Canadian Medical Devices Agency, will talk about Important ideas around AI such as ensuring representativeness of data and reducing bias. They will also discuss how to approach various requirements, including the 21st Century Cures Act in the US, and the EU AI Act, which was. It was approved earlier this year.
The next meeting on Tuesday will focus on How generative AI is used In patient care, with Stryker and intelligent surgical speakers.
3. The future of US diagnostic regulations
In April, d The FDA has finalized a rule Clarity laboratory developed tests should be regulated as medical devices. Since then, the rule has come under pressure from lab trade groups and is a focus Two big ones lawsuits.
The first date for the LDT law is set for May 6, 2025, but it is possible that the law may be delayed in court or Congress may come up with an alternative proposal. On Wednesday, prosecutors and Roche’s head of regulatory policy will speak with the head of AdvamedDx, a division of Advamed. The LDT rule and how Congress and future elections may affect other diagnostic initiatives.
4. International Regulations
The conference will also address other significant international medtech regulations, including Europe’s transition to the new Medical Device Regulation (MDR) and China’s volume-based procurement policy.
The EU published the first New medical device regulations in 2017But the European Commission has Extended schedule For most devices, body-certified certification is due by 2027 or 2028. A Meeting on Wednesday Provides an organizational update.
Medical device regulation in China is also a focus for many large medtech companies. Companies including Johnson & Johnson and GE Healthcare have appealed to China Volume-based procurement policyAnti-corruption and a Slow – anticipated rollout Financial incentive program as a challenge in the past year. On Tuesday, Medtronic and GE Healthcare business leaders in China will talk about the current situation in the country. Market dynamics.
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